UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023508 |
|---|---|
| Receipt number | R000027076 |
| Scientific Title | For the improvement of lower limbs muscle cramps in the dialysis in the hemodialysis patient |
| Date of disclosure of the study information | 2016/08/05 |
| Last modified on | 2020/05/02 19:44:49 |
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Basic information
Public title
For the improvement of lower limbs muscle cramps in the dialysis in the hemodialysis patient
Acronym
Effect of the ergometer working under assistant player to a hemodialysis patient
Scientific Title
For the improvement of lower limbs muscle cramps in the dialysis in the hemodialysis patient
Scientific Title:Acronym
Effect of the ergometer working under assistant player to a hemodialysis patient
Region
| Japan |
Condition
Condition
Hemodialysis
Classification by specialty
| Nephrology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
I inspect an effect of the ergometer working under assistant player for muscle cramps in the dialysis of the hemodialysis patient
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1.Dialysis-related muscle symptom
2.Health-related QOL
Key secondary outcomes
1.Dialysis-related item
2.Knee extension muscular strength
3.Performance
4.exercise tolerability
5.grasping power
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
I perform ergometer working under assistant player during hemodialysis
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The person who is ambulant in the dialysis patients with the suit of lower limbs muscle cramps in dialysis
Key exclusion criteria
The person who cannot walk using welfare tools either
The person that an agreement is not provided
The person who judged that a researcher or a coworker was inappropriate
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takahiro Tamatani |
Organization
Kawashima Hospital
Division name
Department of rehabilitation
Zip code
Address
1-1-39 Kitasako,Tokushima,770-5848,japan
TEL
088-631-0110
reha.tamatani@khg.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takahiro Tamatani |
Organization
Kawashima Hospital
Division name
Department of rehabilitation
Zip code
Address
1-1-39 Kitasako,Tokushima,770-5848,japan
TEL
088-631-0110
Homepage URL
reha.tamatani@khg.or.jp
Sponsor or person
Institute
Kawashima Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
None
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
川島病院(徳島県)
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 08 | Month | 05 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 07 | Month | 22 | Day |
Date of IRB
| 2016 | Year | 06 | Month | 10 | Day |
Anticipated trial start date
| 2016 | Year | 07 | Month | 22 | Day |
Last follow-up date
| 2017 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 08 | Month | 05 | Day |
Last modified on
| 2020 | Year | 05 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027076
